Regulatory Operations Specialist
1 month ago
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to shape the future of clinical development by fostering an inclusive environment that drives innovation and excellence.
We're seeking a skilled Director, Regulatory Operations to join our dynamic team. As a key member, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Responsibilities- Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
- Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
- Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
- Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
- Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.
- Bachelor's degree in a scientific or related field.
- 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of global regulatory requirements and guidelines.
- Proven track record of successful regulatory submissions and approvals.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
- A competitive salary range: $120,000 - $180,000 per year, depending on location and experience.
- An annual leave entitlement of 20-25 days, depending on location and seniority.
- A range of health insurance offerings to suit your needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- A Global Employee Assistance Programme offering 24-hour access to a global network of professionals who can support you and your family's well-being.
- Lifelong learning opportunities to enhance your skills and career prospects.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. At ICON, diversity, inclusion, and belonging are fundamental to our culture and values, and we strive to create a workplace where everyone feels valued and empowered to succeed.
-
Head of Regulatory Operations
5 days ago
Livingston, West Lothian, United Kingdom ICON plc Full timeDirector, Regulatory Operations OpportunityWe are seeking a seasoned professional to fill the role of Director, Regulatory Operations at ICON plc.In this position, you will oversee regulatory operations activities, develop and implement regulatory strategies, and contribute to the advancement of innovative treatments and therapies.Key Requirements:Bachelor's...
-
Associate Laboratory Specialist
2 weeks ago
Livingston, West Lothian, United Kingdom IQVIA Argentina Full timeWe are looking for a talented Associate Laboratory Specialist to join our team at IQVIA Argentina.Job Summary:The successful candidate will perform routine laboratory testing procedures and gather data for use in drug development and clinical trials research.Follows SOPs and regulatory guidelines for performing and documenting analytical procedures.Conducts...
-
Kitchen Operations Specialist
2 months ago
Livingston, West Lothian, United Kingdom beBee Professionals Full time £22,000 - £28,000beBee Professionals in Livingston is seeking a skilled Kitchen Operations Specialist to join our culinary team. As a key member of our kitchen team, you will be responsible for managing a specific section of the kitchen, ensuring that high culinary standards are met consistently.Key Responsibilities:Oversee the preparation and presentation of dishes in your...
-
Warehouse Operations Specialist
3 weeks ago
Livingston, West Lothian, United Kingdom JBT Corporation Full timeRole Summary: We are seeking a highly skilled Warehouse Operations Specialist to join our team at JBT Corporation. As a key member of our logistics team, you will be responsible for managing inventory, processing shipments, and maintaining accurate records.Compensation Package: This role offers a competitive salary of £28,000 - £32,000 per annum, based on...
-
Operational Support Specialist
2 months ago
Livingston, West Lothian, United Kingdom beBee Professionals Full time £25,000 - £35,000We're seeking Operational Support Specialists to join our team at beBee Professionals in Livingston. As a key member of our team, you'll provide exceptional customer service and support, contributing to our operational success.Key Responsibilities:Engage with customers to deliver outstanding service and support.Participate in all aspects of our operational...
-
Commercial Operations Director
1 month ago
Livingston, West Lothian, United Kingdom Young's Seafood Full timeJob DescriptionWe are seeking an experienced Commercial Operations Director to lead our manufacturing facility operations. The successful candidate will oversee daily and weekly operational meetings to ensure compliance with safety, quality, and regulatory standards.
-
Workshop Operations Specialist
2 days ago
Livingston, West Lothian, United Kingdom Rise Technical Recruitment Limited Full timeAbout the RoleWe are recruiting for a Workshop Operations Specialist to join our team in Livingston. As a key member of our workshop team, you will be responsible for ensuring the smooth operation of our facilities and providing technical support to our staff.The ideal candidate will have excellent communication skills and be able to work effectively in a...
-
Maintenance Operations Specialist
2 weeks ago
Livingston, West Lothian, United Kingdom DS Smith Full timeAbout the RoleWe are seeking a skilled Maintenance Operations Specialist to join our team at DS Smith in Livingston. As a key member of our Engineering function, you will play a crucial role in delivering world-class service and driving business growth.This exciting opportunity involves coordinating and conducting routine preventive and reactive asset...
-
Laboratory Research Specialist
3 weeks ago
Livingston, West Lothian, United Kingdom IQVIA Argentina Full timeJob OverviewThe Laboratory Research Specialist role at IQVIA Argentina entails performing routine analysis and laboratory testing procedures to gather data for use in drug development and clinical trials research.Key responsibilities include adhering to SOPs and regulatory guidelines, conducting routine data analysis, identifying and documenting performance...
-
Warehouse Operations Specialist
2 months ago
Livingston, West Lothian, United Kingdom beBee Professionals Full time £20,000 - £25,000We are seeking a skilled Warehouse Operations Specialist to join our logistics team in Livingston, United Kingdom. The ideal candidate will have experience handling goods, preparing orders, and maintaining inventory accuracy.Key Responsibilities:Loading and unloading goods for storage and distribution.Picking, packing, and preparing orders for...
-
Associate Director, Clinical Operations
2 weeks ago
Livingston, West Lothian, United Kingdom IQVIA Argentina Full timeJob DescriptionIQVIA Argentina is seeking a highly skilled professional to fill the position of Associate Director, Clinical Operations. The successful candidate will be responsible for overseeing the clinical operations team, ensuring high-quality results and compliance with regulatory requirements.Main ResponsibilitiesTeam Management: Lead a team of...
-
Whisky Warehouse Operations Manager
4 weeks ago
Livingston, West Lothian, United Kingdom Nine Twenty Recruitment Full timeOur client, a leading Drinks Industry company, is looking for a skilled Whisky Warehouse Operations Manager to oversee the maturation process.Estimated salary: £55,000 - £70,000 per annum.The successful candidate will be responsible for maintaining manufacturing policies and procedures to ensure compliance with regulatory and departmental...
-
Operations Team Member
1 month ago
Livingston, West Lothian, United Kingdom Plexus Malaysia Sdn Bhd Full timeJob DescriptionAs a Field Operator at Plexus Malaysia Sdn Bhd, you will be responsible for ensuring compliance with quality policy guidelines, customer specifications, and regulatory requirements. You will also demonstrate competency in job knowledge and skills, handle additional assignments, and adapt to new work requirements with minimal supervision.
-
Operations Manager
3 days ago
Livingston, West Lothian, United Kingdom Young's Seafood Full timeJob Description:This role involves ensuring efficient production processes, maintaining high-quality standards, and driving continuous improvement initiatives to achieve operational excellence.Main Responsibilities:Lead daily and weekly operational meetings to oversee daily operations of the manufacturing facility, ensuring compliance with safety, quality,...
-
Procurement Operations Specialist
5 days ago
Livingston, West Lothian, United Kingdom Sky Ireland Limited Full timeA career-defining opportunity awaits you at Sky Ireland Limited, where innovation meets creativity with 24 million customers across six countries.This role as a Procurement Operations Specialist offers the chance to drive the supplier onboarding experience.Contribute to ad hoc activities that align with business objectives.Excel (pun intended) in MS Office,...
-
Business Operations Specialist
7 days ago
Livingston, West Lothian, United Kingdom PT Renewables 🌳 Full timeAre you looking for a career in the construction and energy sector?About PT RenewablesWe are a specialist company that delivers high-quality services to major infrastructure projects, power distribution systems, and EV charging solutions.Our team is expanding, and we are seeking a Commercial Assistant to join us on our journey. As a trusted partner to...
-
Kitchen Operations Specialist
2 months ago
Livingston, West Lothian, United Kingdom beBee Professionals Full time £22,000 - £28,000beBee Professionals in Livingston is seeking a skilled Kitchen Operations Specialist to join our culinary team. As a key member of our kitchen team, you will be responsible for managing a specific section of the kitchen, ensuring that high culinary standards are met consistently.Key Responsibilities:Oversee the preparation and presentation of dishes in your...
-
Medical Device Quality Specialist
7 days ago
Livingston, West Lothian, United Kingdom Entrust Resource Solutions Full timeRole SummaryThis is a challenging and exciting opportunity for a Senior Quality Specialist to join Entrust Resource Solutions and lead the QA team. The successful candidate will have a strong background in biomedical engineering or chemical engineering and be able to drive company-wide quality improvements.The ideal candidate will have a high degree of...
-
Operations Support Specialist
3 weeks ago
Livingston, West Lothian, United Kingdom Comex 2000 UK Ltd Full timeJob SummaryWe are seeking an experienced Operations Support Specialist to join our team at Comex 2000 UK Ltd. This is a unique opportunity to work in a dynamic environment and contribute to the success of our projects.About the RoleThe successful candidate will be responsible for coordinating customer delivery, managing job queues and queries, and providing...
-
Quality Assurance Lead Specialist
2 weeks ago
Livingston, West Lothian, United Kingdom Eurofins BioPharma Product Testing Ireland Ltd Full timeRole Summary:Eurofins BioPharma Product Testing Ireland Ltd seeks a skilled Quality Assurance Lead Specialist to oversee our Quality Management System within pharmaceutical finished products, APIs, and raw materials.This role involves managing quality KPIs and metrics, approving procedures, protocols, reports, and certificates of analysis, and hosting client...